Understanding the Supplier Audit Process
Check out our latest video and let us know what you think!
Category: Audit
5W2H of Process Audits: What You Should Know
August 24, 2015
Audit, Quality Control
We’ve used 5W2H to discuss Product Quality Control before, and now we’re using this popular tool to provide insight regarding process audits. Who? Quality auditors are often certified and/or have other applicable training specific to the types of audits they perform. Quality auditors must be professional, ethical and objective. They …
On-Site: What’s a C-TPAT Security Audit?
June 25, 2015
Audit
I’ve recently returned from a visit to our offices in China where I was able to attend a C-TPAT audit with our Supplier Development Manager, Jean Champlain. A C-TPAT audit isn’t quite as common as a general QMS or ISO 9001 evaluation, but the information generated has significant value when …
Are ISO 13485 and FDA 21 CFR Part 820 audits the same?
March 5, 2015
Audit, Quality Control
Our recent newsletter Feature Article highlighted ISO 13485 audits applicable to the medical device industry. A common question we receive in relation to regulatory requirements in the U.S. is the relationship to FDA 21 CFR Part 820. To ensure medical devices are safe and effective, the U.S. Food and Drug …
ISO 13485:201X Preparation (Medical Device Audits)
January 26, 2015
Audit
ISO 13485:2003 is a standard issued by the International Organization for Standardization that specifies requirements for a medical device manufacturer to maintain a quality management system. According to the standard, these requirements “can be used by an organization for the design and development, production, installation and servicing of medical devices, …
Top 3 Benefits of C-TPAT Audits
April 16, 2014
Audit
Although the program started in 2001, there continues to be a lack of understanding regarding what C-TPAT is and how it benefits and adds organizational value. What is it? “The U.S. Customs-Trade Partnership Against Terrorism initiative (C-TPAT) is a voluntary U.S. Customs and Border Protection program designed to improve border …
An Introduction to Auditing – The How & Why
November 21, 2013
Audit
We saw this video posted recently and thought it was such an excellent introduction to audits that we had to share. We’ve also written a few articles related to auditing: Preparing for an Audit Top 3 Factory Audit Components Social Accountability Audits Sustainability Audits